NMRR Malaysia: Registering a Study in the National Medical Research Register

The National Medical Research Register (NMRR) is Malaysia’s online register and submission gateway for medical and health research, operated under the National Institutes of Health (NIH) Malaysia, an agency of the Ministry of Health (MOH). The current platform is NMRR version 2.0, at nmrr.gov.my.

The single thing most investigators get wrong about NMRR is this: registering a study in NMRR is not the same as obtaining ethics approval for it. They are two different things, they produce two different identifiers, and in NMRR v2.0 they are two separate selections on the same form. Registration is a prerequisite that gets your study into the system and routed onward; ethical approval is granted by the Medical Research and Ethics Committee (MREC) and must be requested explicitly. This guide walks the actual submission workflow as documented in NMRR’s own investigator manual, names the two identifiers and why confusing them causes real delays, and flags the one selection that becomes permanently unavailable if you skip it on first submission.

What NMRR is, and who operates it

NMRR describes itself as “a platform where information, progress and conduct of clinical trial, medical & health related research can be shared publicly,” with the stated aim to “coordinate & encourage medical research in Malaysia.”

Two bodies matter for anything you submit:

• The NMRR Secretariat, based at the National Institutes of Health (NIH) Malaysia, processes research registration submissions. It is the Secretariat that reviews your registration and, if satisfied, moves the submission forward.
• The Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, is the ethics review body. NMRR is the route to MREC, not a substitute for it — NMRR’s own FAQ calls the system “the preferred system for applying to the review bodies including MREC (for ethical approval).”

NMRR therefore plays a dual role that is worth separating in your own project plan: it is a public research register (a transparency function, comparable in purpose to clinical trial registration on other national and international registries) and it is an application portal that carries submissions to review bodies. The registration function is automatic on submission; the application functions are not.

Which research must be registered in NMRR

The scope rule is stated directly in NMRR’s general FAQ, and it is broader than “clinical trials”:

“All research related to Ministry of Health (undertaken by Ministry of Health (MOH) personnel or conducted in MOH facilities or using MOH data/patient/personnel as subject or funded by an MOH Research Grant) shall require registration in NMRR.”

Read that as four independent triggers. Any one of them is sufficient:

1. The research is undertaken by MOH personnel;
2. It is conducted in an MOH facility;
3. It uses MOH data, patients or personnel as subjects; or
4. It is funded by an MOH Research Grant.

This catches a great deal of work that investigators do not think of as regulated research — a retrospective case-note review in a government hospital, a service-evaluation questionnaire administered to MOH staff, a student project using MOH patient records. NMRR’s registration categories reflect that breadth. The Research Type options in NMRR v2.0 include Interventional, Observational, Qualitative Research, Mixed Method Research, Proof of Concept / Theoretical Research, Applied Research, Registry / Biobanking / Clinical Database, Clinical Audit / Quality Assurance / Quality Control, Systematic Review / Scoping review / Rapid-review / Meta-analysis / Meta-synthesis, and Special Write Up.

There is a second, separate reason every member of the team needs an NMRR account. Under Malaysian Good Clinical Practice, all principal investigators and sub-investigators on a study team are reviewed by MREC — which means the whole study team must be registered in NMRR so that MREC has records to review. A principal investigator who registers the study but leaves co-investigators unregistered has an incomplete submission, not a minor omission. (On where the line between the two roles actually falls for regulatory purposes, see principal investigator vs. sub-investigator.)

Registration is not ethics approval: where the two actually separate

This is the section worth reading twice, because the distinction is not conceptual — it is a specific control on a specific screen.

“Purpose of Submission” is the mechanism

In NMRR v2.0, a single research submission carries a Purpose of Submission Listing, which is a mandatory field with three options:

• Research Registration — per the investigator manual, this is “auto selected on initial creation of research submission”;
• Scientific Review & Ethical Approval — the MREC route, which you must select;
• Grant (MRG) Submission — the MOH Research Grant application route, which you must also select if you want it.

That first bullet is the whole problem in one line. Because Research Registration is ticked for you automatically, an investigator can complete every mandatory field, submit successfully, receive confirmation that the submission is being processed, and reasonably believe they have “submitted to NMRR for approval” — having never requested ethics review at all. Nothing in that sequence errors. The submission is valid; it simply asked for registration and nothing else.

Selecting Scientific Review & Ethical Approval opens an additional section of the form requiring the MREC document set (detailed below). Only once every mandatory document in that section is uploaded does the section tick as complete.

The Research ID is not the NMRR ID

The second identifier trap is flagged in the official manual with unusual emphasis. When you first create a submission and the General Information section is saved, the system immediately issues an identifier — and the manual’s own remark against that step reads:

“Research ID is a reference ID of the research submission from this point onwards. However, this is not a NMRR Registration ID !!”

So there are two identifiers, issued at different stages and meaning different things:

• The Research ID is issued the moment a submission is created. It confirms only that a draft record exists. At this stage the submission status is “Pending Submission” — meaning it has not yet been sent to the NMRR Secretariat at all.
• The NMRR ID (the NMRR Registration ID) is issued once the research submission has actually been registered. The manual refers to the state “once research submission has been registered and issued NMRR ID” as a distinct, later milestone.

Practical consequence: if a sponsor, journal, funder or ethics committee asks for “the NMRR number” and you supply the Research ID from an unsubmitted draft, you are quoting a reference to a record that has never reached the Secretariat. Check the submission status before you quote an identifier anywhere.

The Grant (MRG) selection is a one-way door

This is the single most costly ordering mistake available in the system, and it is stated explicitly in the manual:

“Submission for Grant (MRG) Application would require user to select both ‘Scientific Review & Ethical Approval’ and ‘Grant (MRG) Submissions’ together during the initial new research registration submission. Once research submission has been registered and issued NMRR ID, the selection of Grant (MRG) Submission will not be accessible in the Purpose of Submission Section.”

In other words: if you intend to apply for an MOH Research Grant, you must select the grant purpose on the initial submission, alongside ethical approval. Once the study has been registered and its NMRR ID issued, that option is gone from the form. Register first and decide about the grant later, and the grant route for that submission is closed.

How to register a study in NMRR, step by step

The following sequence follows the NIH investigator manual for NMRR v2.0.

Prerequisites, before you start

• An NMRR v2.0 account with a role selected at account registration — either Investigator or Clinical Research Associate (CRA).
• A completed profile page. This is a stated prerequisite for submission, not a nicety. Profile completion covers basic information, user information and institution information.
• Note two profile constraints that cost time if discovered late: only PDF files may be uploaded in the profile section, and your email address and identification number are not editable — changing either requires contacting the NMRR Secretariat.
• Institution information is selected by searching the establishment database. If your establishment is not listed, you request its addition from the system administrator through the support page or by emailing the Secretariat with the official name, address and contact details. Keep this current: institution information is displayed in the directory and is extracted into the prefilled IAHODIA form available at submission time.

Step 1 — Create the submission and capture the Research ID

Start a new research submission and complete the General Information section: Submission Type, Research Title, Public Title, Research Title Abbreviation, Protocol ID, Research Scope and Research Type (all mandatory except Protocol ID). On saving, a page displays with the submission information at the top and a Research ID is issued, indicating the submission has been successfully created. Status: “Pending Submission”. Remember: this is not yet the NMRR ID, and nothing has been sent anywhere.

Step 2 — Complete the study sections

Work through the remaining mandatory sections listed down the right of the page. Study Information requires Research Type Information, Study Information, Disease and/or Research Area, Inclusion/Exclusion Criteria, Study Timeline, Subject (Sample Size) Description, Sites Description, Current Study Recruitment Status, Outcome Measures, Ethical Application Status and Study URL. Interventional studies additionally require Investigational Products; interventional and registry/biobanking/clinical-database studies additionally require Biospecimen Collection / Archiving.

Study Site requires a Study Site Listing. Investigator & Sponsor Updates requires the Study Team, Corresponding Person, Sponsor and Contract Research Organisation (CRO) details. Interventional studies also require a Contact for Public Queries; interventional and observational studies also require an SAE Corresponding Person and a PD (protocol deviation) Corresponding Person — nominate these deliberately, because they are the named routes for safety and deviation correspondence for the life of the study.

Step 3 — Add Scientific Review & Ethical Approval as a purpose of submission

Once the registration sections are complete, select Scientific Review & Ethical Approval to open the MREC section, and upload the required documents. Three mechanical rules from the manual, each of which causes avoidable rework:

• Only PDF format is accepted, and the manual warns to “ensure the file name has extension ‘.pdf’ at the end of its name. Files without the extension ‘.pdf’ may have the risk of not being able to be read later.”
• Every uploaded file must be labelled with a version and a version date. File names can be changed at upload if needed.
• Each subsection must be saved separately, using the save control at the end of that subsection. Compulsory documents are marked with the instruction “This document(s) is/are required*”.

Step 4 — Confirm and submit

When all mandatory sections are complete, acknowledge the submission in the Confirmation of Submission section and submit for NMRR processing. The status changes from “Pending Submission” to “Processing Submission by NMRR Secretariat”. Only at this point is the submission genuinely with the Secretariat.

What the submission statuses mean, and when you can still edit

NMRR v2.0 exposes a small set of statuses that determine what you are still allowed to do. Knowing which state you are in prevents both premature reporting and lost edits.

• Pending Submission — created but not yet submitted for NMRR processing. Editable. Deletable.
• Processing Submission by NMRR Secretariat — with the Secretariat. This is the state a successful submission enters.
• Revision Required / Incomplete Submission / Revision Required — returned to you for correction. Editable again; the “Incomplete Submission / Revision Required” state is also deletable at NMRR Registration level.

The edit control is available only for submissions in “Pending Submission”, “Revision Required” or “Incomplete Submission/Revision Required”. A submission sitting with the Secretariat is not editable — which is why completeness before submission matters more here than in systems that let you patch a live application.

One live operational caveat worth planning around: as displayed on nmrr.gov.my at the time of writing (August 2026), the site carries a notice that “the email notification function in the NMRR system is currently experiencing technical issues,” and advises investigators to “log in to the NMRR system periodically to check the latest status.” Do not treat silence as no news. Poll the system.

The MREC document set

Where Scientific Review & Ethical Approval is selected, NMRR collects the MREC dossier. The full document list in NMRR v2.0 comprises:

• Research Documents — Cover Letter to MREC; Declaration of Conflict of Interest (COI form); Study Protocol; and, for interventional research, a Study Protocol Checklist.
• Patient/Participant Information Sheet — Patient Information Sheet (PIS) and Informed Consent Form (ICF), plus a PIS/ICF checklist for interventional research; Information Sheet and Assent Form for minors aged 7–12; Information Sheet and Assent Form for minors aged 13 to under 18. For interventional research there are further optional forms: a PIS/ICF for genetic, pharmacodynamic or pharmacogenomic studies; a PIS/ICF for future research; and a Pregnant Partner Information Sheet and Informed Consent Form.
• Checklists — for interventional research, a Checklist for First Research Protocol, and a Checklist for Research on Stem Cell & Cell Based Therapy for the National Stem Cell Research and Ethics Subcommittee (NSCERT).
• Study conduct documents — Clinical Report Form / Data Collection Form; Questionnaire; Interview Guideline (qualitative and mixed-method research); Project Gantt Chart; Investigator’s Brochure, Advertisement and Patient Diary (interventional research).
• Agreements and approvals — Insurance Indemnity; Memorandum of Understanding / Research Agreement / Clinical Trial Agreement (CTA); Letter from Other Ethical Committee, or from another Approval Body (NSCERT, NRDHM, MDA, First-In Human Committee).
• Other — Other Related Documents; Reason Not to Provide Document; and Investigator Documents, uploaded from the Investigator & Sponsor section.

The mandatory subset varies by Research Type. Interventional research carries the heaviest mandatory load (Research Documents, Patient/Participant Information Sheet, Clinical Report Form / Data Collection Form and Project Gantt Chart are all mandatory). Qualitative and mixed-method research additionally make the Interview Guideline mandatory. At the light end, Systematic Review / Scoping review / Rapid-review / Meta-analysis / Meta-synthesis and Special Write Up require only Research Documents as mandatory, with Gantt chart and investigator documents alongside.

Note the “Reason Not to Provide Document” field. It exists precisely so that a genuinely inapplicable document can be accounted for rather than silently omitted. Use it — an unexplained gap and an explained one are not read the same way.

Common reasons an NMRR submission is returned or stalls

Drawn from the constraints the system and the manual make explicit, rather than from anecdote:

1. Ethics review was never actually requested. The most common conceptual failure: Research Registration is auto-selected, Scientific Review & Ethical Approval is not. A registered study with no ethics purpose selected has not been submitted to MREC.
2. Assuming NMRR’s mandatory-field validation equals MREC’s expectations. This is stated outright in the manual: “Different research type may also require certain documents to be uploaded and submitted to MREC (even it is not a mandatory document during NMRR Submission). Therefore, user is advised to be aware of the required documents. User may refer to MREC Secretariat or its SOP for more information.” Passing NMRR’s form validation is not evidence that MREC has what it needs.
3. Non-PDF uploads, or PDFs without a .pdf extension. Only PDF is accepted; a file lacking the extension risks being unreadable downstream.
4. Unversioned documents. Every uploaded file requires a version label and version date. Ethics committees track document versions against approvals; an unversioned protocol cannot be cleanly approved or amended later.
5. Subsections not saved individually. Uploading without saving each subsection separately loses the upload.
6. An incomplete study team. All principal and sub-investigators are reviewed by MREC and therefore all must be registered in NMRR.
7. Incomplete profile, or an establishment missing from the database. Both are prerequisites; the establishment addition is a Secretariat request with its own turnaround, so do it early rather than mid-submission.
8. Grant intent declared too late. As above — the Grant (MRG) Submission purpose is unavailable once the NMRR ID has been issued.
9. Missing the return notification. With email notifications degraded, a submission moved to “Revision Required” can sit untouched. Log in and check.

Where NMRR sits in Malaysia’s clinical research approval stack

NMRR and MREC handle registration and ethics. They do not authorise the trial itself. For an interventional trial of a medicinal product in Malaysia, product-level authorisation is a separate workstream through the National Pharmaceutical Regulatory Agency (NPRA) — see our guide to the NPRA Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) approval process. Treat NPRA authorisation and NMRR/MREC review as parallel tracks with independent timelines and document sets, not as sequential dependencies.

The wider Malaysian research-governance context is covered elsewhere on this site: MCRCR, Malaysia’s Code of Responsible Conduct in Research sets the integrity expectations investigators are held to; MyRA is the instrument by which Malaysian universities’ research performance is assessed; and Malaysia’s FRGS and MOHE grant schemes cover the higher-education funding routes that sit outside the MOH Research Grant handled inside NMRR.

For the underlying international standards that MREC review is built on, see ICH E6(R3) and our guide to what changed in Good Clinical Practice, and — for the protocol itself — the SPIRIT 2025 checklist. Broader registration and results-reporting obligations are covered in clinical trial registration and reporting compliance. This guide sits in our clinical research cluster.

What we could not verify, and where to get it

In keeping with our sourcing policy, we state gaps rather than fill them with plausible numbers:

• MREC review timelines and meeting frequency. We could not verify these against a primary source. The MREC submission procedure page at nih.gov.my/mrec/submission-form-procedure/ was unreachable at the time of writing (it returns a redirect to a plain-HTTP host that does not respond). Obtain current timelines from the MREC Secretariat directly rather than from third-party summaries.
• Fees. We found no primary-source statement of MREC or NMRR fees and make no claim about them.
• The exact format of an NMRR Registration ID. The investigator manual is emphatic that the Research ID is not the NMRR ID, but does not publish the NMRR ID’s format. Take the value the system displays; do not construct or infer one.
• Categories of review (full board, expedited, exempt) and how MREC assigns them. Not verifiable from the sources we could reach. Refer to the MREC Secretariat or its SOP — which the NMRR manual itself names as the authority on document requirements beyond NMRR’s own mandatory set.

Primary sources used: the NMRR portal; the NMRR general FAQ; and the NIH User Guideline for Investigator/Clinical Research Associate (CRA) — New Research Registration & Other Submission Purposes, National Medical Research Register v2.0, Version 2.0, November 2023, published on nmrr.gov.my. Procedures change; verify against the current version of the manual before relying on any step here.

Frequently asked questions

What is NMRR in Malaysia?

NMRR is the National Medical Research Register, Malaysia’s online register and submission gateway for medical and health research, operated under the National Institutes of Health (NIH) Malaysia within the Ministry of Health. It functions both as a public register of research and as the portal through which studies are submitted to review bodies including the Medical Research and Ethics Committee (MREC).

Is NMRR registration the same as ethics approval?

No. Registration and ethical approval are separate purposes of submission within the same NMRR form. Research Registration is auto-selected when you create a submission; Scientific Review & Ethical Approval must be selected explicitly and requires its own document set. A study can be validly registered in NMRR without ever having been submitted to MREC.

Is NMRR registration mandatory before MREC review?

Yes for research within NMRR’s scope. NMRR is the route through which submissions reach MREC, and because all principal and sub-investigators on a study team are reviewed by MREC, the whole study team must be registered in NMRR. Registration is the prerequisite; it is not the approval.

Which studies have to be registered in NMRR?

All research related to the Ministry of Health — research undertaken by MOH personnel, conducted in MOH facilities, using MOH data, patients or personnel as subjects, or funded by an MOH Research Grant. Any one trigger is sufficient, and the requirement extends well beyond clinical trials to observational, qualitative, audit and registry work.

What is the difference between a Research ID and an NMRR ID?

The Research ID is issued as soon as you create a submission and serves as a reference for that submission; the NMRR investigator manual states explicitly that it “is not a NMRR Registration ID”. The NMRR ID is issued once the research submission has actually been registered. Quoting a Research ID from an unsubmitted draft as your NMRR number is a common and consequential error.

Can I add an MOH Research Grant application to a study I already registered?

No. The manual states that Grant (MRG) Submission must be selected together with Scientific Review & Ethical Approval during the initial new research registration submission, and that once the submission has been registered and issued an NMRR ID, the Grant (MRG) Submission option is no longer accessible in the Purpose of Submission section.

What file formats does NMRR accept?

PDF only, in both the profile section and the ethics document upload section. The manual specifically warns to ensure the file name ends with the .pdf extension, as files without it risk being unreadable later. Each document also needs a version label and version date, and each subsection must be saved separately.

Can I edit a submission after sending it to the NMRR Secretariat?

Not while it is in “Processing Submission by NMRR Secretariat”. Editing is available for submissions with the status “Pending Submission”, “Revision Required” or “Incomplete Submission/Revision Required”. Because you cannot patch a submission that is under review, completeness before submitting matters more here than in systems that permit in-flight amendment.

Does NMRR registration replace NPRA approval for a clinical trial?

No. NMRR registration and MREC ethical approval are separate from product-level trial authorisation, which for medicinal products runs through the National Pharmaceutical Regulatory Agency (NPRA) as a Clinical Trial Import Licence (CTIL) or Clinical Trial Exemption (CTX). Plan them as parallel workstreams with independent timelines.